We aim to perform an in-depth investigation into the role of the mucosal immune response in the pathogenesis of rheumatoid arthritis. Our objectives are to study the presence of RA-specific autoantibodies and several other biomarkers (cytokines,…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The detection of several RA associated antibodies and their distinct antibody
features in feces, saliva and sputum of patients. This will be compared to the
autoantibody profile in serum. Among the distinct antibody features that will
be explored are isotype usage, fine-specificity, glycosylation of Fc- and
Fab-region, avidity and affinity.
Secondary outcome
The presence and characteristics of other biomarkers reflecting the mucosal
immune response in feces, saliva and sputum of patients with RA and healthy
controls. These biomarkers include: the presence of (anti-)inflammatory
cytokines and chemokines and the structure and origin of antigens. Furthermore,
collaboration with other centers may allow the investigation of the microbiome
composition in the future.
Background summary
A subset of rheumatoid arthritis (RA) patients harbour antibodies against
several post-translational modifications and are frequently positive for
rheumatoid factor. The exact pathophysiology of the development of the
autoantibody response and of RA remains unknown. Investigations into genetic
and environmental risk factors and systemic immune dysregulation have led to
the hypothesis that the mucosal surfaces might be involved in the pathogenesis
of seropositive RA. It is proposed that tolerance against post-translational
modifications is broken at the mucosa, inducing an cascade leading to a
systemic inflammatory response and clinical disease.
Study objective
We aim to perform an in-depth investigation into the role of the mucosal immune
response in the pathogenesis of rheumatoid arthritis. Our objectives are to
study the presence of RA-specific autoantibodies and several other biomarkers
(cytokines, antigens and microbiome) in mucosal fluids of RA-patients.
Study design
At the rheumatology department of the LUMC a cross-sectional study will be
performed in which peripheral blood, feces, saliva and sputum (optional) from
patients with rheumatoid arthritis and healthy controls are collected and
several clinical (patient) characteristics will be recorded.
Study burden and risks
Participant will need to self-collect feces. Saliva is collected by the passive
drooling method. Blood sampling will be performed at the central blood draw
facility of the LUMC and a questionnaire will be used to collect clinical
parameters. If participants give additional consent for sputum donation, sputum
induction will take place using a disposable device, the LungFlute®, through
which they have to breath out several times. The risks of this study are
limited to the collection of peripheral venous blood and sputum. Any symptoms
caused by blood sampling or sputum induction are usually mild and symptoms will
recover fully and spontaneously. The participants do not benefit from this
study, but their participation could lead to improved future therapeutic care
for RA patients.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
- Age 18 years or older
- Ability to understand the patient information form and ability to provide
written informed consent
- Written informed consent
For patients:
- a definite diagnosis of rheumatoid arthritis based on the ACR/EULAR 2010
criteria for RA
For healthy controls:
- No previous prolonged and/or current symptoms of inflammatory arthritis
Exclusion criteria
- Individuals who fail to meet the inclusion criteria
- Individuals for whom relevant safety issues apply (for example, dyspnoea or
severe anaemia) that preclude the provision of sputum, saliva, peripheral blood
or feces
- Individuals who are currently suffering from upper airway infections,
influenza or other contagious (lung)diseases
- Dental treatment within the previous month
- The presence of oral ulcers
- Individuals with known inflammatory bowel disease
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL71319.058.19 |